Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps

Myofascial Pain Syndrome Clinical Trial

Official title:

The Effectiveness of Exercise and Dry Needling Treatment Combination in Patients With Nocturnal Calf Cramps

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04789811
• Other study ID #: Biruni University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: June 2021
• Source: Kars State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Investigators aim to evaluate the effectiveness of dry needling treatment in addition to stretching exercises on cramp duration, cramp intensity, cramp frequency, sleep quality, and sensitivity of myofascial trigger points in patients with nocturnal calf cramp.

Description:

Nocturnal leg cramps are sudden, involuntary, painful contractions of the lower extremity in the nighttime, most often in the calf muscles, that gradually lessens. Its etiology is not clear. It can be seen in electrolyte disturbances, drug side effects, neuromuscular diseases, diabetes mellitus, peripheral vascular pathologies. It has been mentioned in the literature that myofascial trigger points in the gastrocnemius muscle may be associated with nocturnal calf cramps. Our aim in this study is to evaluate the effectiveness of the combination of stretching exercises and dry needling therapy on cramp duration, cramp intensity, cramp frequency, sleep quality, and algometer measurement in patients with nocturnal calf cramps and whose had myofascial trigger point in the gastrocnemius muscle.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with only nocturnal calf cramp
• Patients with a trigger point in the unilateral gastrocnemius muscle
• Being between the ages of 18-50

Exclusion Criteria:

• Patients using diuretics or hypertension medications that may trigger cramping
• Those with a chronic disease history
• Those diagnosed with spinal stenosis
• Electrolyte disturbance in laboratory tests

Related Conditions & MeSH terms

• Fibromyalgia
• Muscle Cramp
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Nocturnal Leg Cramps
• Spasm

Intervention

Other:
• Stretching exercise
Stretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks.
• Dry needling
Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.

Locations

Country	Name	City	State
Turkey	Kars State Hospital	Kars

Sponsors (1)

Lead Sponsor	Collaborator
Kars State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in calf cramp duration	How many seconds the patient feels cramp is questioned. Higher values represent a worse outcome	3 months
Primary	Change in Number of Cramps	How many times a day the patient feels cramp is recorded. Higher values represent a worse outcome	3 months
Primary	Change in cramp intensity levels with visual analog scale	How intense the cramp felt by the patient was recorded with a visual analog scale. The score is between 0 to 10, and higher values represent a worse outcome.	3 months
Primary	Change in algometric sensitivity measurement	Myofascial trigger point sensitivity in the gastrocnemius muscle was measured with an algometer. Higher scores represent a worse outcome.	3 months
Primary	Change in sleep quality	The sleep quality of the patients was evaluated with the Pittsburgh Sleep Quality index. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	3 months